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Table 2 Duration of Severe Neutropenia

From: Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy

 

RGB-02

Reference

Difference(RGB-02 - Reference)

Cycle 1, PP population

 n

112

111

 

 Mean (SD)

1.7 (1.14)

1.6 (1.31)

 

 Least squares mean (95% CI)

1.5 (1.2, 1.8)

1.4 (1.1, 1.7)

0.1 (−0.2, 0.4)

Cycle 1, FAS

 n

121

117

 

 Mean (SD)

1.8 (1.28)

1.7 (1.45)

 

 Least squares mean (95% CI)

1.6 (1.3, 1.9)

1.4 (1.1, 1.7)

0.1 (−0.2, 0.4)

Cycle 2, PP population

 n

111

100

 

 Mean (SD)

0.7 (0.81)

0.7 (0.97)

 

 Least squares mean (95% CI)

0.7 (0.4, 0.9)

0.6 (0.4, 0.8)

0.1 (−0.2, 0.3)

Cycle 2, FAS

 n

117

116

 

 Mean (SD)

0.7 (0.81)

0.9 (1.31)

 

 Least squares mean (95% CI)

0.5 (0.3, 0.8)

0.8 (0.5, 1.0)

-0.2 (−0.5, 0.1)